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New drug ARO-HSD tested for fatty liver disease NASH

NCT ID NCT04202354

Disease control Sponsor: Arrowhead Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental drug called ARO-HSD in 50 healthy volunteers and people with NASH, a serious fatty liver disease. The main goal was to check safety and how the drug moves through the body. It's an early step to see if ARO-HSD might be a future treatment for NASH.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ARO-HSD injection
What this could lead to
If successful, this could point toward a treatment for NASH, a serious liver disease with no approved therapies.
What could go wrong
This is a very early, small study (50 people) focused on safety and dosing, not on curing NASH. Many early-stage drugs fail to show benefit in larger trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

50 people

The number who actually took part.

Started

Mar 2020

Finished

Sep 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception * Willing to provide written informed consent and to comply with study requirements * On a stable diet for at least 4 weeks with no plans to significantly alter diet or weight over course of study * Normal electrocardiogram (ECG) at Screening * No abnormal finding of clinical relevance (other than NASH, suspected NASH in patients) at Screening that could adversely impact subject safety during the study or adversely impact study results. Exclusion Criteria: * Clinically significant health concerns (other than NASH, suspected NASH in patients) * Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B Virus (HBV), seropositive for Hepatitis C Virus (HCV) * Uncontrolled hypertension * Excessive use of alcohol within three months prior to Screening * Use of illicit drugs within 1 year prior to Screening, or positive urine drug screen at Screening * Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study NOTE: additional inclusion/exclusion criteria may apply, per protocol \- \-

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non - alcoholic steatohepatitis

Contacts and locations

Locations

  • Auckland Clinical Studies

    Grafton, Auckland, 1010, New Zealand

More trials for these conditions

Other studies related to the condition(s) this trial covers.